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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, positioning, electric
Regulation Description Electric positioning chair.
Product CodeINO
Regulation Number 890.3110
Device Class 2

MDR Year MDR Reports MDR Events
2021 49 49
2022 29 33
2023 29 29
2024 20 26
2025 30 30
2026 14 17

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Device Problem Term/Code Not Available 116 116
Electrical /Electronic Property Problem 16 26
No Apparent Adverse Event 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Unintended System Motion 5 5
Material Too Rigid or Stiff 4 4
No Audible Alarm 4 7
Fire 3 3
Use of Device Problem 3 3
Mechanical Problem 2 2
Device Fell 2 2
Improper or Incorrect Procedure or Method 2 2
Unintended Collision 1 1
Smoking 1 1
Sharp Edges 1 1
Sparking 1 1
Patient Device Interaction Problem 1 1
Material Integrity Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 117
Bruise/Contusion 13 13
Bone Fracture(s) 11 11
Burn(s) 11 11
Abrasion 8 8
Damage to Ligament(s) 6 6
Pressure Sore/Ulcer 5 5
Laceration(s) 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Limb Fracture 2 2
Pain 2 2
Cellulitis 1 1
Loss of consciousness 1 1
Superficial (First Degree) Burn 1 1
Numbness 1 1
Muscle/Tendon Damage 1 1
Fall 1 1
Hip Fracture 1 1
Cardiac Arrest 1 1
Insufficient Information 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Altimate Medical, Inc. II Nov-16-2022
2 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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